Allogene's CAR-T Therapy Shows Promise in Lymphoma, Positioning for Market Leadership

Allogene Therapeutics has unveiled promising phase 1 data for its CD19 CAR-T cell therapy, cemacabtagene ansegedleucel (cema-cel), in relapsed/refractory large B-cell lymphoma (LBCL). The results suggest that the allogeneic treatment could potentially surpass both autologous and allogeneic competitors in the field.

Impressive Efficacy and Durability

The ALPHA and ALPHA2 studies, involving 87 heavily pretreated LBCL patients, demonstrated overall response rates (ORR) and complete response (CR) rates comparable to approved autologous CD19 CAR-T therapies. The treatment regimen selected for the ongoing ALPHA3 phase 2 study showed particularly strong results:

• ORR of 67% and CR rate of 58%
• Median durability of response of 23.1 months
• Progression-free survival of 24 months for patients achieving CR
• Median overall survival not yet reached

Dr. Zachary Roberts, Allogene's Chief Medical Officer, emphasized the significance of these findings: "With multiple patients in ongoing complete remissions beyond four years, the lingering question of whether an allogeneic CAR-T could deliver durable responses has now been answered."

Strategic Positioning and Market Potential

Analysts from William Blair believe cema-cel has the potential to "leapfrog" other CAR-T therapies and expand the total addressable market. The therapy's efficacy in patients with low tumor burden is particularly noteworthy, with all six such patients achieving complete responses.

This data supports cema-cel's potential as a therapeutic option for patients with minimal residual disease and its ongoing development in a frontline remission consolidation setting. Dr. Roberts highlighted the unique opportunity presented by the ALPHA3 trial: "If successful, ALPHA3 has the potential to redefine the standard of care in oncology by predicting and intervening before relapse."

Allogene's Strategic Focus

While Allogene recently abandoned plans for cema-cel in leukemia due to competition from therapies like Bristol Myers Squibb's Breyanzi, the company is forging ahead in lymphoma. The latest data represents the largest and longest follow-up dataset for an allogeneic CAR-T product in LBCL patients.

Allogene's pipeline diversity is also noteworthy, with other promising candidates including:

• ALLO-316: A CD70-targeting CAR-T showing success in a phase 1 renal cell carcinoma trial
• ALLO-329: A CD19/CD70 dual CAR-T in preclinical development for autoimmune diseases

As Allogene continues to advance its allogeneic CAR-T platform, the pharmaceutical industry will be closely watching the progress of cema-cel and the potential shift in treatment paradigms for lymphoma and other indications.